NCT00651209

A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)

A Single-arm, Multinational, Two Year Study Evaluating the Efficacy and Safety of lead-in Telbivudine for 24 Weeks With or Without Tenofovir Treatment Intensification in Adult Patients With HBeAg-positive Chronic Hepatitis B.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Tenofovir	All patients receive 600 mg/day, oral telbivudine for 24 weeks. Patients with non-detectable HBV DNA continue 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 1) Patients with detectable HBV DNA receive 300 mg/day, oral tenofovir plus 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 2)

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-12-01
• First posted: 2008-04-02
• Last updated: 2014-03-07

Locations

4 sites across 4 countries: Argentina, Brazil, Germany, Thailand